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Improvement of Foodallergy Diagnostic in Gastrointestinal Tract

Primary Purpose

Food Allergy

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cytobrush
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all patients with suspicion of food intolerance and confirmed food allergy

Exclusion Criteria:

  • pregnant and patients under allergy medication (antihistaminic, cortison)

Sites / Locations

  • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-NurembergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Food allergy

healthy controls

gastointestinal symptoms without foodallergy in blood

Arm Description

Patients with confirmed foodspecific- IgE antibodies in blood

participants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms

Patients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms

Outcomes

Primary Outcome Measures

detection of specific IgE Antibodies in colon

Secondary Outcome Measures

Full Information

First Posted
May 10, 2017
Last Updated
September 28, 2021
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03151252
Brief Title
Improvement of Foodallergy Diagnostic in Gastrointestinal Tract
Official Title
Improvement of Foodallergy Diagnostic in Gastrointestinal Tract With a New Kind of Sampling
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s controversial. Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food allergy
Arm Type
Other
Arm Description
Patients with confirmed foodspecific- IgE antibodies in blood
Arm Title
healthy controls
Arm Type
Other
Arm Description
participants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms
Arm Title
gastointestinal symptoms without foodallergy in blood
Arm Type
Other
Arm Description
Patients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms
Intervention Type
Diagnostic Test
Intervention Name(s)
Cytobrush
Intervention Description
During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.
Primary Outcome Measure Information:
Title
detection of specific IgE Antibodies in colon
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all patients with suspicion of food intolerance and confirmed food allergy Exclusion Criteria: pregnant and patients under allergy medication (antihistaminic, cortison)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdaguel Zopf, Prof
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Tietz
Email
esther.tietz@uk-erlangen.de
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof
Email
yurdaguel.zopf@uk-erlangen.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
33600102
Citation
Dieterich W, Tietz E, Kohl M, Konturek PC, Rath T, Neurath MF, Zopf Y. Food Intolerance of Unknown Origin: Caused by Mucosal Inflammation? A Pilot Study. Clin Transl Gastroenterol. 2021 Feb 17;12(2):e00312. doi: 10.14309/ctg.0000000000000312.
Results Reference
derived

Learn more about this trial

Improvement of Foodallergy Diagnostic in Gastrointestinal Tract

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